Washed Microbiota Transplantation for Allergic Rhinitis

NCT06372184 | Not Yet Recruiting

• 1 other identifier: WMT-AR-RCT
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Allergic rhinitis (AR) is characterized by sneezing, nasal congestion, nasal itching and nasal leakage and is caused by immunoglobulin E (IgE)-mediated reactions to inhaled allergens. Increasing evidence showed that gut microbiota could influence the development of AR, and we found that washed microbiota transplantation (WMT) could improve nasal symptoms in clinical practice. This clinical trial aims to evaluate the efficacy and safety of WMT for AR.

Conditions

Rhinitis, Allergic

Keywords

washed microbiota transplantation; allergic rhinitis; reflective total nasal symptom score; rhinoconjunctivitis quality of life questionnaire score; gut microbiota

Outcome Measures

Primary Outcomes (1)

• Changes in the reflective total nasal symptom score (rTNSS)

  TNSS is expressed as the sum of the scores for the four nasal symptoms (nasal congestion, rhinorrhea, nasal itching, and sneezing) in the past 12 hours. Each symptom was rated on a 4-point scale from 0 (none) through 1 (mild), 2 (moderate), and 3 (severe).

  baseline, one weeks, four weeks, twelve weeks post WMT

Secondary Outcomes (8)

• Changes in the rhinoconjunctivitis quality of life questionnaire (RQLQ) score

  baseline, one weeks, four weeks, twelve weeks post WMT

• Changes in the single reflective nasal symptoms score

  baseline, one weeks, four weeks, twelve weeks post WMT

• Changes in the concentration of specific IgE

  baseline, one day, four weeks, twelve weeks post WMT

• Changes in the concentration of inflammatory factors

  baseline, one day, four weeks, twelve weeks post WMT

• Changes in the number of immune cell

  baseline, one day, four weeks, twelve weeks post WMT

Study Arms (2)

Washed microbiota transplantation

EXPERIMENTAL

Patients take four capsules containing washed microbiota once a day for five consecutive days

Drug: Washed Microbiota Transplantation

Placebo

PLACEBO COMPARATOR

Patients take four capsules in the same packaging as the experimental group once a day for five consecutive days

Drug: Placebo

Interventions

Washed Microbiota Transplantation DRUG

Patients take four capsules containing washed microbiota once a day for five consecutive days

Also known as: Fecal Microbiota Transplantation

Washed microbiota transplantation

Placebo DRUG

Patients take four capsules in the same packaging as the experimental group once a day for five consecutive days

Also known as: Capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years old.
• Meets the diagnostic criteria for allergic rhinitis.
• rTNSS score greater than or equal to 6 points.
• The subject or his/her legal representative gives informed consent, fully understands the purpose of the study, is able to communicate effectively with the investigator, and comprehends and complies with the requirements set forth in the study.

You may not qualify if:

• Patients with acute nasosinusitis or upper respiratory tract infection.
• Patients diagnosed with chronic sinusitis, nasal septum deviation, nasal polyps, nasal tumors, and other nasal diseases or have undergone nasal surgery.
• Antibiotics, PPI, probiotics, and other drugs that alter gut microbiota were used in the past two weeks.
• Patients with poor lung function.
• Patients with severe liver, kidney, and heart diseases
• Patients with known psychiatric or neurological diseases.
• Patients who use antihistamines, glucocorticoids, decongestants, mast cell membrane stabilizers, leukotriene antagonists in the past two weeks.
• According to the judgment of the investigator, the subjects are not suitable to participate in this clinical study, or participation in this clinical study cannot guarantee the rights and interests of the subjects.

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead

Study Sites (1)

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

Location

Related Publications (7)

• Wise SK, Damask C, Roland LT, Ebert C, Levy JM, Lin S, Luong A, Rodriguez K, Sedaghat AR, Toskala E, Villwock J, Abdullah B, Akdis C, Alt JA, Ansotegui IJ, Azar A, Baroody F, Benninger MS, Bernstein J, Brook C, Campbell R, Casale T, Chaaban MR, Chew FT, Chambliss J, Cianferoni A, Custovic A, Davis EM, DelGaudio JM, Ellis AK, Flanagan C, Fokkens WJ, Franzese C, Greenhawt M, Gill A, Halderman A, Hohlfeld JM, Incorvaia C, Joe SA, Joshi S, Kuruvilla ME, Kim J, Klein AM, Krouse HJ, Kuan EC, Lang D, Larenas-Linnemann D, Laury AM, Lechner M, Lee SE, Lee VS, Loftus P, Marcus S, Marzouk H, Mattos J, McCoul E, Melen E, Mims JW, Mullol J, Nayak JV, Oppenheimer J, Orlandi RR, Phillips K, Platt M, Ramanathan M Jr, Raymond M, Rhee CS, Reitsma S, Ryan M, Sastre J, Schlosser RJ, Schuman TA, Shaker MS, Sheikh A, Smith KA, Soyka MB, Takashima M, Tang M, Tantilipikorn P, Taw MB, Tversky J, Tyler MA, Veling MC, Wallace D, Wang Y, White A, Zhang L. International consensus statement on allergy and rhinology: Allergic rhinitis - 2023. Int Forum Allergy Rhinol. 2023 Apr;13(4):293-859. doi: 10.1002/alr.23090. Epub 2023 Mar 6.

  PMID: 36878860 BACKGROUND

• Bousquet J, Anto JM, Bachert C, Baiardini I, Bosnic-Anticevich S, Walter Canonica G, Melen E, Palomares O, Scadding GK, Togias A, Toppila-Salmi S. Allergic rhinitis. Nat Rev Dis Primers. 2020 Dec 3;6(1):95. doi: 10.1038/s41572-020-00227-0.

  PMID: 33273461 BACKGROUND

• Martensson A, Cervin-Hoberg C, Huygens F, Lindstedt M, Sakellariou C, Greiff L, Cervin A. Upper airway microbiome transplantation for patients with chronic rhinosinusitis. Int Forum Allergy Rhinol. 2023 Jun;13(6):979-988. doi: 10.1002/alr.23122. Epub 2023 Jan 1.

  PMID: 36515012 BACKGROUND

• Zhang T, Lu G, Zhao Z, Liu Y, Shen Q, Li P, Chen Y, Yin H, Wang H, Marcella C, Cui B, Cheng L, Ji G, Zhang F. Washed microbiota transplantation vs. manual fecal microbiota transplantation: clinical findings, animal studies and in vitro screening. Protein Cell. 2020 Apr;11(4):251-266. doi: 10.1007/s13238-019-00684-8. Epub 2020 Jan 9.

  PMID: 31919742 RESULT

• Schaefer M, Zimmermann K, Enck P. Probiotic treatment (Enterococcus faecalis) improves symptoms of seasonal allergic rhinitis: A randomized controlled trial. Int Forum Allergy Rhinol. 2023 Oct;13(10):1974-1977. doi: 10.1002/alr.23154. Epub 2023 Apr 7. No abstract available.

  PMID: 36922364 RESULT

• Anania C, Di Marino VP, Olivero F, De Canditiis D, Brindisi G, Iannilli F, De Castro G, Zicari AM, Duse M. Treatment with a Probiotic Mixture Containing Bifidobacterium animalis Subsp. Lactis BB12 and Enterococcus faecium L3 for the Prevention of Allergic Rhinitis Symptoms in Children: A Randomized Controlled Trial. Nutrients. 2021 Apr 16;13(4):1315. doi: 10.3390/nu13041315.

  PMID: 33923532 RESULT

• Kang MG, Han SW, Kang HR, Hong SJ, Kim DH, Choi JH. Probiotic NVP-1703 Alleviates Allergic Rhinitis by Inducing IL-10 Expression: A Four-week Clinical Trial. Nutrients. 2020 May 15;12(5):1427. doi: 10.3390/nu12051427.

  PMID: 32429063 RESULT

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Fecal Microbiota Transplantation; Capsules

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Faming Zhang, MD,PhD

  The Second Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faming Zhang, MD,PhD

CONTACT

086-25-58509883; fzhang@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Gastroenterology

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 17, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

CN (1)